Loratadine

Product NDC
60760-831
11-digit product format
607600831
Labeler code
60760
Product ID
60760-831_45750216-7bf6-d3c9-e063-6294a90a16cb
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-01-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-831-00Loratadine100 in 1 BOTTLE, PLASTICTABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-831-00EA - Each60760-831d4308191-62f6-4c77-b041-7039ff471fe212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-831LORATADINE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20250117_2bc586e4-5297-44cf-e063-6294a90a531d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN2bc586e4-5297-44cf-e063-6294a90a531d2
311372loratadine 10 MG Oral TabletSCD2bc586e4-5297-44cf-e063-6294a90a531d2
311372loratadine 10 MG 24 HR Oral TabletSY2bc586e4-5297-44cf-e063-6294a90a531d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-831-0060760083100100 TABLET in 1 BOTTLE, PLASTIC (60760-831-00) 100 tablet2024-01-01NoNoHistorical